Drug application
PERIKABIVEN IN PLASTIC CONTAINER (AMINO ACIDS, CALCIUM CHLORIDE, DEXTROSE and 5 more)
Drugs@FDA NDA 200656 · FRESENIUS KABI USA
Key facts
| Drug name | PERIKABIVEN IN PLASTIC CONTAINER |
|---|---|
| Active ingredients | AMINO ACIDS, CALCIUM CHLORIDE, DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, SODIUM ACETATE, SODIUM GLYCEROPHOSPHATE, SOYBEAN OIL |
| Application type | NDA |
| Application number | 200656 |
| Company | FRESENIUS KABI USA |
| Dosage forms | EMULSION, INTRAVENOUS |
| Strength | 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML) |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission class | Type 2 - New Active Ingredient |
| Latest submission status date | Aug 25, 2014 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: